NDA 018555

ASTRAZENECA

FDA Drug Application

Application #018555

Application Sponsors

NDA 018555

ASTRAZENECA

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

10MG

0

YUTOPAR

RITODRINE HYDROCHLORIDE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	1980-12-12	STANDARD
LABELING; Labeling	SUPPL	2	AP	1996-03-27
LABELING; Labeling	SUPPL	5	AP	1996-03-27
LABELING; Labeling	SUPPL	7	AP	1996-03-27
LABELING; Labeling	SUPPL	11	AP	1986-04-17
LABELING; Labeling	SUPPL	12	AP	1986-11-19
LABELING; Labeling	SUPPL	13	AP	1987-06-23
LABELING; Labeling	SUPPL	14	AP	1996-03-27	STANDARD
LABELING; Labeling	SUPPL	15	AP	1996-03-27	STANDARD

CDER Filings

ASTRAZENECA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 18555
            [companyName] => ASTRAZENECA
            [docInserts] => ["",""]
            [products] => [{"drugName":"YUTOPAR","activeIngredients":"RITODRINE HYDROCHLORIDE","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"YUTOPAR","submission":"RITODRINE HYDROCHLORIDE","actionType":"10MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)